- Reform to lower prescription drug prices, save up to NIS 200m. ($55,763,000) (jpost.com)
High-priced prescription drugs will soon become 5% cheaper, thanks to simplification of the mechanism that controls their maximum permitted prices. This will lead to savings of NIS 150m. to NIS 200m., the Treasury and Health ministries announced...“This is an additional step to reduce the cost of living and make health more accessible to the public,” Finance Minister Moshe Kahlon said. “This change is part of a series of steps we have taken in the past three years to strengthen the public health system”...ministries have been working on implementing a reform in the mechanism for determining the maximum prices of prescription drugs...The committee carried out international reviews and consultations with representatives of health funds and the pharmaceutical companies. It decided to revise the drug price-control model to bring down the prices of expensive prescription drugs and increase the supply of inexpensive medications...
- How big data can design safer clinical trials and reduce animal testing (outsourcing-pharma.com)A big data approach to the concordance of the toxicity of pharmaceuticals in animals and humans (sciencedirect.com)
Bayer AG and Elsevier studied more than 1.6m adverse events to show how big data can be used to reduce animal testing and design trials "altered to potential risks," says researcher...The entire life sciences industry is committed to reducing animal testing, and all organizations are looking at how this can be done effectively...The study analyzed 1,637,449 adverse events (AEs) reported for both humans and the five most commonly used animals in US Food and Drug Administration and European Medicines Authority regulatory documents for 3,290 approved drugs and formulations...published in the Journal of Regulatory Toxicology and Pharmacology...We already know that animal testing has some predictive capabilities for humans but there has never been a study on this broad scale before to look at the level of exact concordance...Of the study’s key results...the species most frequently used in toxicology (rat and dog)...are performing well with regard to identifying adverse events in humans...also...the negative predictive value is low for many adverse events...no findings in animal often does not mean that no adverse events will occur in humans...some effects observed in some animal species do not imply high risk for humans...The analysis allows a researcher to estimate the human risk implied by a given observed effect in an animal...With access to this kind of information, researchers can design safer clinical trials in the future...
- Right to Try bill clears House, headed for Trump signature (biopharmadive.com)
The House of Representatives...voted....to pass Sen. Ron Johnson’s, R-Wis., Right to Try legislation, sending the bill to President Donald Trump’s desk. The vote is the culmination of a multi-year campaign...which aims to provide access to unapproved drugs under review at the Food and Drug Administration to patients facing life-threatening illnesses with no further options...The bill covers a much broader population than an earlier House-passed version. The president has been a vocal advocate...it may have unintended effects and potentially hinder FDA’s authority without changes...Conservative groups including Freedom Partners and Americans for Prosperity backed the effort, calling attention to the fact that 40 states have passed versions of Right to Try, a strategy employed by Goldwater to drum up momentum for the bill...The Senate version of the legislation is less safe than the pathway proposed in the House version and is dangerous compared to the current expanded access process...The Senate’s bill would allow unproven therapies to be given to patients without FDA notification for up to a full year and would not establish any standards for informed consent...
- Biotech M&A: will the 2018 surge last? (pharmaceutical-technology.com)
Analysts are predicting a surge of M&A activity in the biotech space, with large pharma firms looking to pad their pipelines with new acquisitions, US tax reform freeing up cash flow, and rapidly-consolidating US healthcare buyers likely to put more pressure on the price of existing drugs. How is the biotech M&A landscape likely to develop over the course of 2018?
- Key drivers of biotech M&A in 2018 - So what are the major drivers spurring this latest biotech M&A push?...The first factor to consider is one that has plagued big pharma for years, and is as big a problem now as ever: the patent cliff.
- Tax reform spurs M&A - Major tax reforms implemented in the US by the Trump administration could also be fueling a surge in large firms snapping up biotech innovators.
- Waiting for a ‘detonator’ - With President Trump’s tax reform something of a detonator in itself, the market may be waiting for a massive merger or acquisition to kick off an M&A feeding frenzy in the biotech space
- Trump signs ‘right to try’ drug bill (thehill.com)
President Trump signed a bill...allowing terminally ill patients access to experimental medical treatments not yet approved by the Food and Drug Administration...Dubbed "right to try," the law's passage was a major priority of Trump and Vice President Pence, as well as congressional Republicans..."Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it's going to better than a chance, that they will be cured, they will be helped, and be able to be with their families for a long time, or maybe just for a longer time," Trump said at a bill signing ceremony at the White House, surrounded by terminally ill patients and their families...Most Democrats and public health groups oppose the bill, arguing that it could put patients in danger...FDA oversight of access to experimental treatments exists for a reason — it protects patients from potential snake oil salesmen or from experimental treatments that might do more harm than good...Opponents also argue it gives “false hope” to patients, since drugmakers aren’t required to give unapproved medicines to patients who ask for them...Supporters say, however, it will provide new treatment opportunities for terminally ill patients who have exhausted existing options...
- Continuous manufacturing: Lower API volumes reduce development costs, says exec (in-pharmatechnologist.com)
Continuous manufacturing can help drugmakers save on development costs by reducing API waste...The continuous – as opposed to batch – method has been revered for its improved product quality and lower outlays, such as reduced good manufacturing practice areas, transport, and storage...The one thing that continuous manufacturing will definitely save you money on, is development..Commercial benefit?...It may look on paper that a batch method is going to be cheaper…but none of that cost will account for batches failing in commercial development, and then not being able to sell that product... The more complex the process it, the more susceptible you are to doing that...
- Early 340B hospitals gave more uncompensated care than later participants (biopharmadive.com)
Hospitals that joined the 340B Drug Pricing Program at its onset provided more uncompensated care and low-profit services to patients than those who joined in its later years, according to a new research letter published in JAMA from researchers at Vanderbilt University and the University of Chicago...Allan Coukell and Sean Dickson...write...that policymakers would be "well served by greater transparency on hospitals' use of 340B revenues," but warn that reductions in 340B eligibility will lead to a transfer from Medicare spending on 340B hospitals to increased revenue for drug manufacturers...In January, a final rule went into effect that cut drug payments to 340B hospitals by almost 30%. The American Hospital Association and other groups are currently suing the U.S. Department of Health and Human Services over the rule. Earlier this month, the U.S. Court of Appeals for the District of Columbia Circuit heard oral arguments for the case...
- Integrating medication management with its EHR helped one hospital beat CMS expectations (healthcareitnews.com)
King's Daughters Medical Center...found it challenging to provide an accurate, verifiable home medication record for its providers to trust as they made important decisions about existing medications both during an inpatient visit and after discharge...King's Daughters now uses external medication history from pharmacy fill data as well as insurance claims data, provided by vendor DrFirst, to complement verification and push the information to the providers...While it is not intended as a replacement for the patient/family interview, its integration into the electronic health record greatly augments the conversation and can prompt a patient to include easily forgotten information...This reduces the risk of prescription loss and makes the process more efficient for the patient while ensuring the health record is updated in advance of future visits...King's Daughters is required to report its performance on both medication reconciliation (with a threshold goal of 50 percent) and e-prescription (10 percent) to the Centers for Medicare and Medicaid Services...most recent reporting period, Q4 2017, our stats were 77 percent and 52 percent, respectively...integrating medication management tech into the EHR also helped King’s Daughters more effectively retrieve historical data and deliver that information to providers to facilitate new prescriptions in a trustworthy manner that both reduces errors and the abuse of controlled substances...
- This Week in Managed Care: May 25, 2018 (ajmc.com)
Samantha DiGrande, Welcome to This Week in Managed Care from the Managed Markets News Network
- May 25 Pharmacy Week in Review: FDA Issues Approvals for 2 Drugs, and a Safety Alert for HIV Medication (pharmacytimes.com)
Nicole Grassano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.